The following is not an admission that anything discussed below is part of the prior art or part of the common general knowledge of a person skilled in the art.
Electronic file management systems are increasingly used to manage medical records. These systems are used to facilitate and streamline various processes such as generating, storing, archiving, searching, reviewing, and reporting electronic medical records. As the size of electronic medical records increases, effective systems for managing and organizing electronic medical records are needed to avoid inefficiencies and backlogs in data transmission and communication. Inefficient or slow file management systems may have a direct impact on clinical efficiency, for instance by increasing the time required for a clinician to retrieve and review each patient file.
A Picture Archiving and Communication System (PACS) provides storage and management of medical image data items. The PACS defines a universal Digital Imaging and Communication in Medicine (“DICOM”) format for communication (e.g. storage and transmission) of image files and related metadata. PACS systems are used in many healthcare disciplines such as, but not limited to, radiology, computed tomography, positron emission tomography, magnetic resonance imaging, ultrasonography, and cardiology. As a result, the DICOM standard and DICOM messaging play a key role in modern digital healthcare, along with other communication protocols such as Health Level Seven International (HL7) standards and Fast Healthcare Interoperability Resources (FHIR) standard.
Medical disciplines involving the collection and review of medical images have increasingly been transitioning to electronic and digital imaging systems. Pathology is one example of such a discipline. Pathology is the study of disease in the human tissue and pathology results are often used as critical test results for diagnostic and therapeutic decisions (e.g. HER2 tissue measures needed to allow for the prescription of certain cancer medications). Pathology can involve microscopic, macroscopic, chemical (molecular biology), and biological analysis of tissue samples.
To cope with increasing workloads, high volume pathology departments are digitizing tissue sample slides as high resolution whole slide images (WSI). These digitized slides are used to reorganize clinical routines and procedures and can also be used in clinical research. The convergence of laboratory medicine, anatomical pathology and digital imaging with biomarker data is dramatically changing how pathology and laboratory medicine is practiced. These in vivo and in vitro diagnostics often need to be translated into integrated reports with data collected from various sources.
In pathology, the transformation to the digital world has been enabled by commercially available digitizing imagers used to digitize microscope slides. Each digitizing imager generates a digital representation of the microscopic slide in one or more data files that together form an electronic medical image data item. However, the transformation to electronic medical images and medical image data items is not without technical challenges.
Different medical imagers may generate medical image data items in different and sometimes proprietary formats. While some of these imaging formats are based on open-source imaging specifications (e.g. TIFF, JPEG, BMP, etc.) with proprietary modifications, others use data formats that are entirely proprietary. As a result, different viewing applications may be required to view medical image data items generated by the different viewers.
Generating medical image data items in different formats may also complicate or limit the ability to integrate medical image data items from different imagers into centralized file management systems for managing medical images, such as a PACS. This may result in electronic workflows being limited to particular departments or laboratories that generate medical image data items in the format defined by a particular file management system. As a result, the electronic workflows may only cover a portion of the necessary steps required for a particular imaging task.
For example, in the case of ultrasound guided biopsies, a tissue acquisition workflow forms part of the PACS system, while the sample processing workflow is outside of the PACS and is thus not visible to the PACS. The same may be true for CT/MR or Endoscopy guided sampling procedures. As a result multiple independent electronic workflows (that may not communicate with another) may be required for a single imaging procedure.
It may be difficult for a clinician to obtain a holistic view of related medical image data items available for the same patient or same type of image when the different imagers and imaging workflows are not integrated into a centralized system. For example, in the case of breast tissue sampling a sample from the same tissue block may be used both to create a microscope slide and to undergo X-Ray imaging. However, the X-Ray image may not be available in the pathology image management system while the pathology is not available in the X-Ray image management system.
A clinician using one image management system may be unable to access images from other systems directly, which may introduce delays as they have to change programs or devices to access the other systems. In some cases, the clinician may not be aware that other images have been captured or are available on other file systems, which could lead to oversights or errors.